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Clinical Trials/ISRCTN77861053
ISRCTN77861053
Completed
Not Applicable

An evaluation of the impact of early initiation of Highly Active Anti-Retroviral Therapy (HAART) on Tuberculosis (TB) treatment outcomes for TB patients co-infected with Human Immunodeficiency Virus (HIV)

World Health Organization (WHO) (Switzerland)0 sites1,900 target enrollmentMarch 29, 2006
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ConditionsTuberculosis (TB) and Human Immunodeficiency Virus (HIV) co-infectionsInfections and InfestationsHuman immunodeficiency virus (HIV)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) co-infections
Sponsor
World Health Organization (WHO) (Switzerland)
Enrollment
1900
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
World Health Organization (WHO) (Switzerland)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 to 65 years
  • •2\. HIV treatment naive patients (established by history)
  • •3\. CD 4 T\-cell count between 220\-500 cells/l
  • •4\. No history of previous anti\-TB chemotherapy
  • •5\. A traceable home address and contact details to facilitate home visits with a firm commitment to remain traceable and to be able to access a defined treatment/service point for 24 months
  • •6\. Not enrolled in any other drug or treatment trials
  • •7\. Informed consent for HIV testing (since the study population will be smear positive TB patients co\-infected with HIV)
  • •8\. Informed consent to participate in the trial
  • •9\. For female subjects, the following conditions are to be met:
  • •9\.1\. Has been post\-menopausal for at least one year, or

Exclusion Criteria

  • •1\. Evidence (laboratory and clinical history) of pre\-existing non\-tuberculosis disease likely to affect the response to, or assessment of treatment effects or represent contraindications to the study medication:
  • •1\.1\. Diabetes mellitus
  • •1\.2\. Liver impairment (alanine aminotransferase \[ALT] or aspartate aminotransferase \[AST] greater than 2 x the upper limit of normal value)
  • •1\.3\. Renal failure (serum creatinine greater than 2\.0 mg/dl)
  • •1\.4\. Epilepsy
  • •1\.5\. Optical neuritis
  • •1\.6\. Pancreatitis (lipase greater than 140 U/l)
  • •1\.7\. Neutropenia (total neutrophil count less than 1200 cells/l)
  • •1\.8\. Severe anaemia (haemoglobin less than 6\.9 g/dl)
  • •1\.9\. Any other condition that in the view of the country Principal Investigator represents a contraindication to the study medication

Outcomes

Primary Outcomes

Not specified

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